Quality Engineer

EliteProTek • Oceanside, CA

4d

About The Position

The Quality Engineer will be responsible for supporting commissioning, qualification, and validation activities, as well as maintaining process/equipment reliability programs including Total Preventive Maintenance. This role requires experience with federal regulations regarding GLP and GMP, and the ability to gather data, prepare reports, and utilize statistical analysis. The position involves developing and monitoring quality improvement plans and SOPs, and providing training and guidance to other QA officers and staff on GMP compliance.

Requirements

• Bachelor of Science Degree
• 2 years of GMP experience
• Knowledge about GMP QE
• Experience with federal regulations regarding GLP and GMP
• Experience with gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables
• Knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines
• Demonstrated ability to develop and monitor quality improvement plans and SOPs

Nice To Haves

• Support Commissioning, Qualification, and Validation activities
• Maintain Process/Equipment reliability programs including a Total Preventive Maintenance

Responsibilities

• Supervising other QA officers, providing training and guidance in day-to-day Good Manufacturing Practices (GMP) compliance activities.
• Training and providing guidance to other staff and facility users/clients.
• Reporting regularly and providing updates to Quality management.
• Performing day-to-day QE activities including support of OOS, deviations, CAPA and change control documents.
• Providing Quality Engineering support of production activities.
• Writing, reviewing, and approving technical assessments of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level